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Spotlight_Barbara Albientz
SPOTLIGHT

Reuters Pharma 2025: Post-Conference Talks Featuring Barbara Albientz

Barbara Albientz, Chief Commercialization Officer, Helvion Pharmaceuticals, joins PharmaShots’ Managing Editor Himanshu Sehgal for a riveting dialogue exchange. Barbara shares her experience from the recently held Reuters Events Pharma 2025, where she joined as an affirmative team member for the debate Reality Check: Is Omnichannel Actually Working? Barbara believes AI will be crucial in segmenting…
May 1, 20250Comments

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J&J
News

Johnson & Johnson Reports the US FDA’s Approval of Imaavy (Nipocalimab-aahu) for Generalized Myasthenia Gravis (gMG)

Shots: The US FDA has approved Imaavy to treat antibody +ve gMG pts (≥12yrs.) under priority review based on the ongoing P-III (Vivacity-MG3) trial assessing Imaavy + SoC vs PBO + SoC in antibody +ve or -ve adults (N=199; 153 were Ab +ve); global regulatory review is ongoing Trial showed superior disease control per MG-ADL…
May 1, 20250Comments

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Teleflex
News

Teleflex’s QuikClot Control+ Hemostatic Device Receives the US FDA’s 510(k) Clearance to Temporary Control All Bleeding Grades

Shots: The US FDA has granted 510(k) clearance for label expansion of QuikClot Control+ Hemostatic Device to control all grades of internal & external bleeding Label expansion was supported by real-world evidence from an observational study evaluating QuikClot Control+ in 603 US emergency, trauma, & surgical pts across all bleeding grades & varied anatomical sites…
April 30, 20250Comments

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Bayar
News

Bayer Reports Post-Hoc Data from P-III (ARANOTE) Trial of Nubeqa to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: Bayer has reported post-hoc analyses from P-III (ARANOTE) trial assessing Nubeqa (darolutamide; 600mg, BID) + androgen deprivation therapy (ADT) (n=446) vs PBO + ADT (n=223) in mHSPC pts (N=669) Post-hoc analyses showed that 42.6% pts achieved ultra-low PSA levels (<0.02ng/mL) vs 7.8% pts on PBO & this response was associated with prolonged rPFS, delayed…
April 30, 20250Comments

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Sandoz & Henlius
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Henlius and Sandoz Enter a Global Collaboration Agreement to Commercialize HLX13 (Biosimilar, Yervoy)

Shots: Henlius has granted Sandoz exclusive rights of the HLX13, a biosimilar version of Yervoy (ipilimumab), which is being assessed in a Henlius-led P-I/III trial for inoperable HCC, targeting enrollment of 656 pts As per the deal, Sandoz will register & market HLX13 in Australia, Canada, EU, Japan, & the US in exchange for milestone-based…
April 30, 20250Comments

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Abbvie
News

AbbVie’s Rinvoq (Upadacitinib) Receives the US FDA’s Approval for Giant Cell Arteritis

Shots: The US FDA has approved Rinvoq (15mg; QD) to treat adults with giant cell arteritis (GCA) following the EC’s Approval in Apr 2025 Approval was based on P-III (SELECT-GCA) trial assessing Rinvoq, where GCA pts (n=428) in 1st study period received either Rinvoq (7.5 or 15mg, QD) + 26wk. corticosteroid (CS) taper regimen or PBO +…
April 30, 20250Comments

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